LIAISON® Lyme Total Antibody Plus: The LIAISON® Lyme Total Antibody Plus assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgG and IgM antibodies to Borrelia burgdorferi in human serum and plasma (K2-EDTA, Li-heparin) samples. This assay is intended for use on samples from patients with signs and symptoms that are consistent with Lyme disease. Positive or equivocal results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results provide evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. Negative results by LIAISON® Lyme Total Antibody Plus assay should not be used to exclude Lyme disease. The test has to be performed on the LIAISON® XL Analyzer.

The LIAISON® Lyme Total Antibody Plus Control Set: The LIAISON® Lyme Total Antibody Plus Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Lyme Total Antibody Plus assay. The performance characteristics of LIAISON® Lyme Total Antibody Plus Control Set have not been established for any other assays or instrument platforms different from the LIAISON® XL.

Device Description

The method for qualitative determination of IgG and IgM antibodies to Borrelia burgdorferi is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the Analyzer. The principal components of the test are magnetic particles (solid phase) coated with recombinant Borrelia antigens and a conjugate reagent containing two mouse monoclonal antibodies (anti- human IgG and anti-human IgM) linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, antigen-specific antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the conjuqates react with Borrelia burgdorferi IgG and IgM antibodies captured by the solid phase. Unbound material is removed with a wash cycle following incubations. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of Borrelia burgdorferi antibodies present in calibrators, samples or controls.

AI/ML Overview

The provided text describes the performance data for the DiaSorin LIAISON® Lyme Total Antibody Plus assay. Here's a breakdown of the acceptance criteria and study details based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in a table format with pass/fail thresholds. Instead, it presents performance data that supports the claim of substantial equivalence to a predicate device. The implied acceptance criteria are that the new device's performance is comparable to or better than the predicate device across various metrics.

However, we can infer some "performance targets" from the "First Tier Percent Agreement with Predicate Device" and "Second Tier Testing" tables.

Performance Metric	Implied Acceptance Criteria (Goal)	Reported Device Performance (LIAISON® Lyme Total Antibody Plus)
First Tier Agreement:
Positive % Agreement (with Predicate)	High agreement with predicate for positive/equivocal results.	56.5% (65/115) with 95% Cl: 47.4% - 65.2%
Negative % Agreement (with Predicate)	Very high agreement with predicate for negative results.	98.7% (1416/1435) with 95% Cl: 97.9% - 99.2%
Second Tier Testing (PPA):
Positive Percent Agreement (with WB)	High agreement with Western Blot for predicate-positive/test-positive cases	97.9% (47/48) with 95% Cl: 89.1%-99.6%
CDC Lyme Reference Sera Agreement:
Stage I Acute Agreement	High agreement with CDC classification.	76.9% (30/39) with 95% CI: 61.7% - 87.4% (Same as Predicate)
Stage II Convalescent Agreement	High agreement with CDC classification.	93.5% (29/31) with 95% CI: 79.3% - 98.2% (Same as Predicate)
Stage III Late Agreement	Very high agreement with CDC classification.	100.0% (20/20) with 95% CI: 83.9% - 100.0% (Same as Predicate)
Look-alike Diseases Agreement	High negative agreement (low false positives).	95.6% (86/90) with 95% CI: 89.1% - 98.3%
Healthy Controls Agreement	Very high negative agreement (low false positives).	98.0% (98/100) with 95% CI: 93.0% - 99.4%
Precision (Total %CV):	Low variability across runs, days, and operators (lower is better).	<15% for most samples (e.g., Neg Control: 11.3%, Pos Control: 10.4%)
Reproducibility (Total %CV):	Consistent results across different sites (lower is better).	<10% for most samples (e.g., Neg Control: 8.2%, Pos Control: 7.2%)
Cross-Reactivity:	Minimal false positives in various disease states.	13 positive/equivocal results out of 238 samples (approx. 5.5%)
Interfering Substances:	Performance not affected by common interferents at specified concentrations.	Performance not affected (details not explicitly quantified beyond "not affected").
Matrix Equivalence:	Equivalent results across different sample types.	Met acceptance criteria (Passing and Bablok regression summary provided).

2. Sample Size Used for the Test Set and Data Provenance

Prospective Study/Method Comparison Agreement:
- Sample Size: 1550 samples.
- Data Provenance: Samples collected from subjects sent to the lab for Lyme disease testing. De-identified and numbered. From five (5) geographical regions of the U.S.
- Retrospective/Prospective: Implied as prospective given the description "samples collected from subjects sent to the lab for Lyme disease testing."
Characterized Lyme Panel (CDC Lyme Reference Sera):
- Sample Size: 280 samples.
- Data Provenance: Acquired from the CDC.
- Retrospective/Prospective: Retrospective, as these are a "characterized" (pre-defined) panel.
Precision Study: 6 serum samples + 1 lot of controls, tested 48 times each.
Reproducibility Study: 6 serum samples + 2 controls, tested 30 times each per site (total of 90 replicates per sample across 3 sites).
Cross-Reactivity Study: 238 specimens from 24 different disease states.
Interfering Substances: Not specified beyond "equivocal B. burgdorferi serum specimens" and listed substances.
Matrix Equivalence Study: 32 matched patient sets (serum, SST serum, K2-EDTA plasma, lithium heparin plasma).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish the ground truth for the test set in the traditional sense of human readers interpreting images.

For the Prospective Study/Method Comparison Agreement, the primary "ground truth" or reference was the predicate device (Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System) and Western Blot testing for positive/equivocal results.
For the Characterized Lyme Panel, the ground truth was the CDC Reference Classification. The qualifications of those who originally established the CDC classifications are not provided in this document.

4. Adjudication Method for the Test Set

Not applicable in the context of this device (an in vitro diagnostic assay). The "adjudication" is based on agreement with a predicate device, Western Blot, or CDC reference classifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is not relevant here as the device is an in vitro diagnostic (IVD) assay for antibody detection, not an AI-assisted diagnostic imaging tool that would involve human reader interpretation. No human readers or AI assistance in interpretation are mentioned.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is also not directly applicable as the device is a laboratory assay. Its "standalone performance" is essentially what is evaluated throughout the document: the assay's ability to detect antibodies and its agreement with established methods and reference panels. There is no "human-in-the-loop" decision-making process for this specific device's output.

7. The Type of Ground Truth Used

Comparative Effectiveness Study:
- The predicate device (Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System) served as a primary comparative ground truth.
- Western Blot (a confirmatory laboratory test) was used as a secondary ground truth for resolving positive or equivocal results.
Characterized Lyme Panel:
- CDC Reference Classification which likely represents a consensus or established characterization based on clinical, serological, and potentially epidemiological data for those samples.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning. This device is a biochemical assay, not an AI/ML algorithm. Therefore, the concept of a training set as typically understood in AI development is not applicable. The development of the assay would have involved various optimization and development studies, but these are not referred to as a "training set."

9. How the Ground Truth for the Training Set was Established

As the device is an IVD assay and not an AI/ML algorithm, there is no "training set" or establishment of ground truth for such a set in the conventional sense of AI. The assay's development and optimization would have relied on biochemical principles and validation against known samples, but the document does not detail these initial development phases or the ground truth used therein.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 29, 2019

DiaSorin Inc. Mari Meyer Vice President of Regulatory & Clinical Affairs 1951 Northwestern Ave Stillwater, Minnesota 55082-0285

Re: K193051

Trade/Device Name: LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR, QCH Dated: October 31, 2019 Received: November 1, 2019

Dear Mari Meyer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Steven Gitterman, M.D., Ph.D. Deputy Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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5.0 510(k) SUMMARY

SUBMITTED BY:	Mari MeyerVP Regulatory and Clinical Affairs, NorthAmerica, DiaSorin Inc.1951 Northwestern AvenueStillwater, MN 55082-0285Phone (651) 439-9710Fax (651) 351-5669Email: mari.meyer@diasorin.com
DATE PREPARED:	January 11, 2020
NAME OF DEVICE:
Trade Name:	LIAISON® Lyme Total Antibody PlusLIAISON® Lyme Total Antibody Plus Control Set
Common Names/Descriptions:	Borrelia burgdorferi IgG/IgM assay andBorrelia burgdorferi IgG/IgM controls
Classification Names:	Treponema pallidum; treponemal test reagentsClass II, 21 CFR: 866.3830; Microbiology
Product Code:	LSR
Predicate Device:	Zeus ELISA Borrelia VIsE1/pepC10 IgG/IgMTest System (K113397)

INTENDED USE:

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KIT DESCRIPTION:

Table 1: Table of Similarities
Characteristic	Candidate Device LIAISON®Lyme Total Antibody Plus	Predicate DeviceZeus ELISA Borrelia VIsE1/pepC10IgG/IgM Test System - K113397
Intended Use	LIAISON® Lyme Total Antibody Plus:The LIAISON® Lyme Total AntibodyPlus assay uses chemiluminescentimmunoassay (CLIA) technology forthe qualitative determination of IgGand IgM antibodies of Borreliaburgdorferi in human serum andplasma (K2-EDTA, Li-heparin)samples. This assay is intended foruse on samples from patients withsigns and symptoms that areconsistent with Lyme disease.Positive or equivocal results shouldbe supplemented by testing with astandardized Western blot procedure.Positive supplemental results provideevidence of exposure to B.burgdorferi and can be used tosupport a clinical diagnosis of Lymedisease. Negative results byLIAISON® Lyme Total Antibody Plusassay should not be used to excludeLyme disease. The test has to beperformed on the LIAISON® XLAnalyzer.	Qualitative detection of IgG and IgM classantibodies to VIsE1 and pepC10 antigensfrom Borrelia burgdorferi in human serum.The assay is intended for testing serumsamples from symptomatic patients orthose with a history of Lyme Borreliosis. Allpositive and equivocal specimens shouldbe tested with a second-tier test such asWestern Blot, which if positive, is supportiveevidence of infection with Borreliaburgdorferi. Diagnosis of LymeBorreliosis should be made based on thepresence of B. burgdorferi antibodies,history, symptoms, and otherlaboratory data. Negative first or secondtier results should not be used to excludeBorreliosis. This kit is for in vitro diagnosticuse.
Results	Qualitative	Same

COMPARISON TO PREDICATE DEVICE

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Measurand	IgG and IgM antibodies to Borreliaburgdorferi	Same
Intended Population	Patients with signs and symptomsconsistent with Borrelia infection(Lyme disease)	Same
Assay Principle	Uses Borrelia antigens coated on asolid phase to capture specific patientantibodies.	Uses B. burgdorferi antigen coated on asolid phase to capture specific patientantibodies.
Sample Type	Human serum, serum separatortubes, K₂-EDTA, lithium heparin plasma	Human serum
Conjugate antibodyspecificities	Anti-human IgG and anti-human IgM	Anti-human IgG/IgM
Assay Output	Index	Same

Table 2:	Table of Differences
Feature	Candidate DeviceLIAISON® Lyme TotalAntibody Plus	Predicate DeviceZeus ELISA BorreliaVlsE1/pepC10 IgG/IgM Test
Test Format	CLIA (indirect chemiluminescentassay)	ELISA
Reporter Molecule	Isoluminol derivative conjugated toanti-human IgG and IgM	TMB (as a substrate for Horseradishperoxidase conjugated to anti-humanIgG/IgM).
Antigen	Recombinant VlsE antigen from B.burgdorferi strain B31 and from B.garinii strain Pbi, and OspC antigenfrom Borrelia afzelii,	VlsE1 and pepC10 antigens of B.burgdorferi
Assay Procedure	Automated (on the LIAISON® XLAnalyzer)	Manual
Calibration	Two-point verification (in triplicate) ofstored 10-point master curve	Single Cut-off Calibrator assayed intriplicate
Output Signal	Flash chemiluminescent response isintegrated over a 3 second readingperiod to generate a relative lightunit (RLU) value.	Microtiter well O.D. (450 nm) is measuredafter the enzyme reaction is halted bysulfuric acid.
Measurement System	Photomultiplier (flashchemiluminescence reader)	Spectrophotometer (EIA Microtiter platereader)

PERFORMANCE DATA:

Prospective Study/Method Comparison Agreement:

One thousand five hundred fifty (1550) samples collected from subjects sent to the lab for Lyme disease testing, were de-identified and numbered. The collection consisted of subjects from five (5) geographical regions of the U.S. The samples were tested with the LIAISON® Lyme Total Antibody Plus assay on the LIASON® XL and performed in three (3) laboratories (2 external and internally at DiaSorin). Results were evaluated for first tier testing.

Table 3: First Tier Percent Agreement with Predicate Device

Predicate Assay (IgG/IgM)

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LIAISON®Lyme TotalAntibody Plus	Positive	Equivocal	Negative	Total
Positive	62	1	9	72
Equivocal	2	0	10	12
Negative	42	8	1416	1466
Total	106	9	1435	1550

Positive % Agreement* 56.5% (65/115) 95% Cl: 47.4% - 65.2% Negative % Agreement 98.7% (1416/1435) 95% Cl: 97.9% - 99.2% *Includes Positive and Equivocal combined

Table 4: Second Tier Testing

Western blot testing was performed on the samples positive or equivocal by the test device and the predicate. The following results were obtained:

Test System	Tier 1 + or Eqv	Western BlotlgG/lgM +	WesternBlotlgG/IgM -
LIAISON® Lyme Total Antibody Plus	84	48	36
Predicate Assay	115	48	67
Predicate + LIAISON® Lyme Total Antibody Plus	65	47	18

Agreement Results:

2nd Tier PPA 97.9% (47/48) 95% Cl: 89.1%-99.6%

15.2 Characterized Lyme Panel

Two hundred eighty samples of various reactivity were acquired from the CDC and evaluated internally at the manufacturer's site. The results of the testing are presented here as a means of conveying further information on the performance of the LIAISON® Lyme Total Ab Plus assay with a characterized serum panel. This does not imply an endorsement of the assay by the CDC.

Table 5: Testing of CDC Lyme Reference Sera

Sample Category (CDCReference Classification)	Candidate			Predicate			N	LIAISON LymeTotal AB Plus% Agreement/95% Wilson CI	Predicate% Agreement/95% Wilson CI
Stage IAcute	Pos	Neg	Eqv	Pos	Neg	Eqv
Stage I Acute	27	9	3	30	9	0	39	76.9% (30/39)61.7% - 87.4%	76.9% (30/39)61.7% - 87.4%
Stage II Convalescent	29	2	0	29	2	0	31	93.5% (29/31)79.3% - 98.2%	93.5% (29/31)79.3% - 98.2%
Stage III Late	20	0	0	20	0	0	20	100.0% (20/20)83.9% - 100.0%	100.0% (20/20)83.9% - 100.0%
Look-alike Diseases	2	86	2	4	85	1	90	95.6% (86/90)89.1% - 98.3%	94.4% (85/90)87.6% - 97.6%
Healthy Controls	2	98	0	3	95	2	100	98.0% (98/100)93.0% - 99.4%	95.0% (95/100)88.8% - 97.8%

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15.3 PRECISION STUDY

A 12-day precision/repeatability study was conducted at DiaSorin on the LIAISON® Lyme Total Antibody Plus assay. Six (6) serum samples and one (1) lot of LIAISON® Lyme Total Antibody Plus Controls were tested for 12 days, 2 runs/day, and 2 replicates per run by multiple technologists for a total of 48 replicates. These test days span 2 calibration cycles. CLSI document EP05-A3 was consulted in the preparation of the testing protocol.

Sample ID	N	Mean(Index)	Within Run		Between Run		Between Day		TOTAL
			SD	%CV	SD	%CV	SD	%CV	SD	%CV
NegControl	48	0.09	0.01	9.4	0.01	8.0	0.00	0.0	0.01	11.3
Pos Control	48	1.96	0.13	6.7	0.03	1.6	0.15	7.7	0.20	10.4
Sample 1	48	0.09	0.00	5.6	0.01	6.0	0.00	2.2	0.01	8.5
Sample 2	48	0.84	0.04	4.5	0.02	2.8	0.05	5.6	0.07	7.7
Sample 3	48	1.59	0.12	7.7	0.00	0.0	0.10	6.0	0.15	9.4
Sample 4	48	4.51	0.21	4.7	0.24	5.4	0.25	5.5	0.41	9.0
Sample 5	48	0.82	0.06	7.3	0.07	8.4	0.06	7.0	0.11	13.2
Sample 6	48	1.39	0.08	6.0	0.12	8.7	0.07	5.2	0.16	11.8

15.4 REPRODUCIBILITY STUDY

A five (5) day precision/reproducibility study was performed internally at DiaSorin Inc. and at two (2) external U.S. laboratories with one (1) lot of LIAISON® Lyme Total Antibody Plus assay. The study was performed for 5 days, 2 runs/day, and 3 replicates/run. Each day, two operators, at each testing site performed the testing for a total of 30 replicates at each site. CLSI document EP15-A3 was consulted in the preparation of the testing protocol.

Sample			Within Run		Between Day		Between Run		Between Site		TOTAL
ID	n	mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Neg Control	90	0.0509	0.002	4.7	0.002	3.4	0.002	3.4	0.002	4.7	0.004	8.2
Pos Control	90	1.8	0.118	6.5	0.04	2.2	0.039	2.2	0.000	0.0	0.13	7.2
Sample 1	90	0.0463	0.002	4.6	0.002	4.3	0.001	3.1	0.000	0.0	0.003	7.0
Sample 2	90	0.654	0.028	4.2	0.036	5.5	0.026	3.9	0.024	3.7	0.057	8.8
Sample 3	90	1.55	0.07	4.5	0.055	3.6	0.046	3.0	0.077	5.0	0.126	8.2
Sample 4	90	4.66	0.207	4.4	0.161	3.5	0.107	2.3	0.000	0.0	0.283	6.1
Sample 5	90	0.86	0.052	6.1	0.04	4.6	0.000	0.0	0.035	4.1	0.074	8.7
Sample 6	90	1.42	0.065	4.6	0.075	5.3	0.041	2.9	0.064	4.5	0.125	8.8

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15.5 Cross-Reactivity Study

The cross-reactivity study was designed to evaluate 238 specimens from twenty four (24) disease states either known to contain potentially cross-reactive antibodies to B. burgdorferi or from patients with diagnoses that can exhibit signs and symptoms similar to late manifestations of Lyme disease and cause false positive results.

Organism Infected or Disease State	SamplesTested(n)	Pos or Eqv
Tick Borne Diseases
Babesiosis	10	4
Tick Borne Relapsing Fever (TBRF)	8	2
Autoimmune Disorders
Anti-Nuclear Antibodies (ANA)	10	0
Multiple Sclerosis	10	0
Sjogrens Syndrome	10	1
Viral Diseases
Cytomegalovirus (CMV) IgM	10	0
Cytomegalovirus (CMV) IgG	10	0
Epstein-Barr Virus (EBV) VCA, and/orheterophile Ab IgM	10	0
Epstein-Barr Virus (EBV) VCA, NA-1 and/orEA-D IgG	10	0
Epstein-Barr Virus (EBV) EBNA IgG	10	1
Epstein-Barr Virus (EBV) VCA IgM	10	2
Epstein-Barr Virus (EBV) VCA IgG	10	0
Human Immunodeficiency Virus (HIV)	10	0
Influenza Virus	10	0
Parvovirus	10	3
Bacterial Diseases
E. coli	10	0
H. pylori	10	0
Syphilis	10	0
Rheumatic Diseases
Fibromyalgia	10	0
Rheumatoid Arthritis	10	0
Rheumatoid Factor	10	0
Systemic Lupus Erythematosus (SLE)	10	0
Additional Markers
Chronic Fatigue Syndrome	10	0
Human Anti-mouse Antibodies (HAMA)	10	0
Total	238	13

15.6 Interfering Substances

Controlled studies of potentially interfering substances from endogenous interferents spiked into equivocal B. burgdorferi serum specimens showed that assay performance was not affected at the concentration for each substance listed below. The testing was based on CLSI-EP7-A3.

Substance	Concentration
Hemoglobin	1000 mg/dL
Triglycerides	1500 mg/dL
Bilirubin	40 mg/dL
Total protein	12 g/dL
Cholesterol	500 mg/dL
Biotin	3600 ng/mL

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15.7 Matrix Equivalence Study

Thirty-two (32) matched patient sets of serum, SST serum, K2-EDTA plasma and lithium heparin plasma samples were tested to determine if these sample types provide equivalent results. Sample regression analysis was done by Passing and Bablok method. All sample types met acceptance criteria for use in the LIAISON® Lyme Total Antibody Plus assay. A summary of the results is shown in the following table.

Sample Equivalence Results:

Comparison to Serum	Bias	CI: 95%
SST Serum Constant	0.00	0.01	0.01
SST Serum Proportional	0.99	0.97	1.01
K2-EDTA Constant	0.01	0.03	0.01
K2-EDTA Proportional	0.99	0.95	1.01
Lithium Heparin Constant	0.01	0.02	0.01
Lithium Heparin Proportional	0.95	0.92	0.97

CONCLUSION:

The material submitted in this premarket notification supports a substantial equivalence decision.

Regulation Number and Section

§ 866.3830

Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).